MedMira’s
Innovation Roadmap
Driven by technology and guided by clinical needs, we advance rapid testing with purpose.
This roadmap outlines the developments shaping our next generation of solutions.
Rapid Testing Refined
Our development pipeline highlights key projects built on our two proprietary platforms, which enable versatile use across human health, food processing, and biosafety testing through both internal development and external partnerships.
Our patented RVF™ technology uses a rapid vertical flow design that shortens time-to-result and provides reliable, high-sensitivity signal detection, proven in validation studies and use across various settings.
Our emerging MiROQ™ platform combines RVF with SERS-based signal enhancement for quantitative liquid biopsy assays, tracking biomarker levels and trends over time – beyond simple yes/no results.
What’s next in our pipeline
Our diagnostic pipeline illustrates the structured progression of tests from early development to regulatory submission. Each product follows a standardized pathway to ensure quality, performance, and regulatory compliance.
The pipeline is organized into five phases:
Phase 1 Product Development
Phase 2 Validation
Phase 3 Pre-Submission
Phase 4 Clinical Trials Phase
Phase 5 Final Submission
This phased structure provides a clear and transparent overview of the current status of each test within the pipeline.
Breast cancer–associated antigen
Tumour-associated protein antigens
Vertical flow immunoassay (RVF technology™)
Single
The Reveal® Breast Cancer Biomarker (CA 15.3) Antigen Rapid Test is developed for the monitoring of breast cancer–associated antigens.
Breast Cancer
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Multiple cancer types (breast, pancreatic, ovarian, gastrointestinal, colorectal, lung, liver, germ cell tumours)
Tumour-associated protein antigens (CA 27.29, CA 15-3, CA 19-9, CA 125, CEA, AFP)
Vertical flow immunoassay (RVF technology™)
Single
Our oncology portfolio comprises rapid tests designed not only for breast cancer–associated markers but also for broader multi-cancer risk assessment. These tests identify panels of cancer-associated biomarkers to support early identification in clinical and research settings.
Multiple cancer biomarkers
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
HIV
HIV-1 and HIV-2 antibodies
Vertical flow immunoassay (RVF technology™)
Single
Enables qualitative detection of HIV-1 and HIV-2 antibodies across multiple specimen matrices. Designed for CLIA use in the U.S., it is currently in the final phase of clinical evaluation.
HIV-1/2
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Trichomonas vaginalis
Antibody against T. vaginalis antigens
Vertical flow immunoassay (RVF technology™)
Single
The Reveal® Trichomoniasis Antibody Rapid Test is developed for the qualitative detection of Trichomonas vaginalis antibody in clinical blood specimens (finger-stick, venous blood, serum and plasma).
Trichomoniasis
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Herpes simplex virus type 2 (HSV-2)
Host-derived antibodies (IgG, IgM)
Vertical flow immunoassay (RVF technology™)
Single
Our HSV-2 serology test focuses on type-specific IgG/IgM detection to help distinguish HSV-2 exposure from other herpesvirus responses. It is designed to support routine STI-related assessments in professional healthcare settings.
HSV-2
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Treponema pallidum (Syphilis)
Treponemal (TP) and non-treponemal (nTP) antibodies
Vertical flow immunoassay (RVF technology™)
Multiple
The Multiplo® Complete Syphilis (TP/nTP) Antibody Test is developed for the qualitative detection of Treponema pallidum (TP) and non-treponemal (nTP) antibodies in clinical whole blood specimens. Currently in the second phase of the clinical validation.
Syphilis (TP)
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
HIV-1/2 and Treponema pallidum (Syphilis)
Host-derived antibodies to HIV-1/2 and Treponema pallidum (TP)
Vertical flow immunoassay (RVF technology™)
Multiple
Intended for the qualitative detection of HIV-1/2 and Treponema pallidum (TP) antibodies in a self-test format. Currently undergoing clinical validation.
Syphilis (TP)
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Neisseria gonorrhoeae (NG) / Chlamydia trachomatis (CT)
Pathogen-derived bacterial protein antigens
Vertical flow immunoassay (RVF technology™)
Multiple
Targets protein antigens specific to Neisseria gonorrhoeae and Chlamydia trachomatis for use in clinical testing environments. Development was supported by grant funding for NG and CT antigen detection.
NG/CT
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Treponema pallidum (TP), Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV)
Pathogen-derived protein antigens and antibodies
Vertical flow immunoassay (RVF technology™)
Multiple
Detects antigens associated with Treponema pallidum, HIV and HCV. Development was supported by grant funding, with validation conducted by the Johns Hopkins University Applied Physics Laboratory.
TP/HIV/HCV
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Hepatitis B virus (HBV)
Host-derived antibodies (anti-HBs, anti-HBc, anti-HBe) and viral antigens (HBsAg, HBcAg and HBeAg)
Vertical flow immunoassay (RVF technology™)
Dual-mode testing
The Multilinx™ HBV Panel is designed to detect key hepatitis B markers, supporting evaluation of infection status and immunological response in clinical testing workflows.
HBV
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5
Treponema pallidum (TP), Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV)
Host-derived antibodies (TP Ab, HIV Ab, HCV Ab) and pathogen-derived viral antigens (HBsAg, HIV-1 p24 Ag, HCV core Ag)
Vertical flow immunoassay (RVF technology™)
Dual-mode testing
Developed and validated by Qualtex, this rapid vertical flow assay is used under RUO conditions. The test enables the detection of antibodies and antigens associated with TP, HIV, HCV and HBV within a single multi-target test device.
TP/HIV/HCV
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Phase 5